A Novel Approach of Substitution Therapy With Inhalation of Essential Oil for the Reduction of Inhalants Craving: A Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Inhalants craving - PACS
研究概览
简要总结
Inhalants, which are neurotoxic central nervous system (CNS) suppressants, are frequently abused by young adults. Unlike other CNS depressants, including alcohol and opiates, no treatment is currently approved for inhalants dependence. In this report, a novel approach of substitution treatment for inhalants addiction was explored in a double-blinded, randomized, controlled crossover design to examine the effects of inhalation of essential oil (EO) and perfume (PF) on the reduction of cue-induced craving for inhalants in a cohort of thirty-four Thai males with inhalants dependence. The craving response was measured by the modified version of Penn Alcohol Craving Score for Inhalants (PACS-inhalants)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The containers for essential oil and perfume are identical dark-glass tubes with a roll-on-cap on top and double-covered with a plain cap on each tube.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with ability to smell if they could correctly identify 3 out of 5 odors, namely fish sauce, lemon, onion, basil, and jasmine.
- •Individuals with inducible picture-cues inhalant craving based on a 50% increase in craving score from baseline.
排除标准
- •Individuals with a history of major psychiatric disorders, including psychotic and mood disorders
- •Individuals with illicit substance dependence other than inhalants
- •Individuals with allergic reactions to essential oil or perfume.
研究组 & 干预措施
Essential oil
Essential oil is prepared from the product of Thailada with manufacture standard ID 1087/2548 by Thailand Ministry of Industry. Essential oil is extracted by a cold compressed method from the lavandula angustifolia (lavender) grown in Australia.
干预措施: Essential oil (Combination Product)
Essential oil
Essential oil is prepared from the product of Thailada with manufacture standard ID 1087/2548 by Thailand Ministry of Industry. Essential oil is extracted by a cold compressed method from the lavandula angustifolia (lavender) grown in Australia.
干预措施: Cue-induced inhalants craving (Behavioral)
Perfume
Perfume is the synthetic perfume of lavender flavor without essential oil.
干预措施: Perfume (Combination Product)
Perfume
Perfume is the synthetic perfume of lavender flavor without essential oil.
干预措施: Cue-induced inhalants craving (Behavioral)
结局指标
主要结局
Inhalants craving - PACS
时间窗: Daily for 3 days
Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)
Inhalants craving - VAS
时间窗: Daily for 3 days
Inhalants craving was measured by the Visual Analog Scale (VAS).
次要结局
未报告次要终点
研究者
Rasmon Kalayasiri
Associate Professor
Chulalongkorn University